Teriparatide as a Chondroregenerative Therapy in OA
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 80
Summary
- Conditions
- Cartilage Degeneration
- Knee Osteoarthritis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a prospective, randomized, placebo controlled, double blinded study. Interim results will determine if there is a crossover.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Researchers, providers, and subjects will be blinded to treatment group so that outcomes will not be influenced by expectations about the experimental treatment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 60 years
- Gender
- Both males and females
Description
This is a prospective, randomized, placebo controlled, double blinded, crossover study. The investigators will identify, recruit and enroll 80 subjects with symptomatic, unilateral medial compartment knee OA. Enrolled subjects will be randomized into equal TP (in the FDA approved form, Forteo) or pl...
This is a prospective, randomized, placebo controlled, double blinded, crossover study. The investigators will identify, recruit and enroll 80 subjects with symptomatic, unilateral medial compartment knee OA. Enrolled subjects will be randomized into equal TP (in the FDA approved form, Forteo) or placebo arms of 40 subjects each (includes allowance for a 25% dropout rate with no replacements). All subjects will be treated for 24 weeks, then followed for an additional 24 weeks to assess the durability of any observed effects. The trial incorporates a crossover design, based on interim analysis of the 24 week outcome data after every subject has completed the 24 week treatment period. If positive effects on structural and/or biomarker measures are apparent from the interim analysis, placebo treated subjects will be offered TP (in the FDA approved form, Forteo) and followed for an additional 24 weeks. If the placebo subjects who choose to participate in the crossover treatment have not yet completed the 48 week visit, it will not occur. These subjects will begin the crossover portion 24 week treatment and monitoring period when they receive the TP pens (in the FDA approved form, Forteo).
Tracking Information
- NCT #
- NCT03072147
- Collaborators
- Eli Lilly and Company
- University of Rochester
- Duke University
- Milton S. Hershey Medical Center
- Investigators
- Principal Investigator: Michael Zuscik, PhD University of Rochester Principal Investigator: Emily Carmody, MD University of Rochester Principal Investigator: Christopher Ritchlin, MD University of Rochester
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